guidelines for medicine safety surveillance in rwanda...guidelines for pharmacovigilance and...

REPUBLIC OF RWANDA

MINISTRY OF HEALTH

Guidelines for Pharmacovigilance and Medicine Information in Rwanda

REPUBLIC OF RWANDA

MINISTRY OF HEALTH

Guidelines for Pharmacovigilance and Medicine

Information in Rwanda


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FOREWORD

On June 26, 2010, the Food and Medicines Act developed by the Ministry of Health was

approved. It identifies the Rwanda Food and Medicines Authority (RFMA) as the regulatory

board of all medicine and food related issues. This document has been submitted to the country’s

high authorities for approval. One of the RFMA’s core mandates is to ensure that the medicines

used in the country are of good quality, safe and efficacious.

As the RFMA is not yet established, the Ministry of Health has entrusted this to the Directorate

of Clinical Services which performs most activities related to pharmaceutical regulations, among

them Pharmacovigilance and medicine information.

Medicines, despite their obvious benefits, can also cause adverse drug reactions (ADRs) which

can be serious or even fatal. ADRs must be reported and analyzed to protect the public health

and improve the patient care.

These guidelines for the National Pharmacovigilance and Medicine Information System in

Rwanda have been developed to ensure that safe, efficacious and quality medicines are made

available to all Rwandans.

I acknowledge the contribution of different units, departments and divisions in the Ministry of

Health (MoH) and Rwanda Biomedical Center (RBC); the National University of Rwanda

(NUR), the World Health Organization in Rwanda and the Management Sciences for Health’s

Strengthening Pharmaceutical Systems (SPS) Program office in Kigali.

Dr. Anita ASIIMWE

Minister of State in Charge of Public Health and Primary Health Care


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CONTENTS

Foreword ......................................................................................................................................... 1

CONTENTS .................................................................................................................................... 2

Acronyms and Abbreviations ......................................................................................................... 4

Introduction ..................................................................................................................................... 5

Establishment of the National Pharmacovigilance and Medicine Information Center .............. 6

Overarching goal of the NPMIC ................................................................................................. 6

Scope of Pharmacovigilance and Medicine Information System in Rwanda ............................. 6

Importance of Pharmacovigilance .............................................................................................. 7

Importance of Unbiased Medicine Information .......................................................................... 8

Adverse Event Notification System for Pharmacovigilance .......................................................... 9

Reporting system ........................................................................................................................ 9

Roles and responsibilities in relation to Pharmacovigilance and Medicine Information ......... 11

NMRA ........................................................................................................................................ 14

Other Stakeholders .................................................................................................................... 15

Medicine Information ................................................................................................................... 17

Literature scan for relevant safety alerts ................................................................................... 17

Risk communication ................................................................................................................. 17

Requesting medicine information ............................................................................................. 17

Information, Education, Communication Materials and NPMIC Publications ........................ 17

Medicine Promotion and Advertising ....................................................................................... 17

Pharmacovigilance Methods ......................................................................................................... 18

Spontaneous Reporting ............................................................................................................. 18

Active Surveillance ................................................................................................................... 24

Some active surveillance methods used in Rwanda ................................................................. 25

Safety Monitoring of Herbal Medicines in the National Pharmacovigilance System .................. 26

Tools for Medicine Safety Surveillance Activities ....................................................................... 27

Adverse event notification form ............................................................................................... 27


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Poor quality medicine notification form ................................................................................... 27

Medicine information request form .......................................................................................... 28

Causality assessment tool ......................................................................................................... 28

Adverse event severity grading scale ........................................................................................ 28

Medication error assessment tool ............................................................................................. 29

Patient Alert Card ..................................................................................................................... 29

Glossary of medicine safety terms ............................................................................................ 29

Capacity Building ......................................................................................................................... 30

Monitoring and Evaluation ........................................................................................................... 30

ANNEXES .................................................................................................................................... 31

Annex A. Adverse Event Notification Form ................................................................................ 32

Annex B. Poor Quality Medicine Notification Form.................................................................... 37

Annex C. Medicine Information Request Form ........................................................................... 41

Annex D. WHO Causality Assessment Criteria ........................................................................... 42

Annex E. WHO Toxicity Grading Scale ....................................................................................... 43

Annex F. Medication Error Reporting and Prevention Scale ....................................................... 46

Annex G. Patient Alert Card ......................................................................................................... 47

Annex H. Glossary of Medicine Safety Terms ............................................................................. 49

Annex I : Definition and classification of ADR ........................................................................... 51


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ACRONYMS AND ABBREVIATIONS

AE

ADR

Adverse Event

Adverse Drug Reaction

AIDS Acquired Immunodeficiency Syndrome

CHW Community Health Worker

DTC Drug and Therapeutics Committee

GoR Government of Rwanda

HIV Human Immunodeficiency Virus

MAH Marketing authorization holder

MoH Ministry of Health

NMSC National Medicine Safety Committee

MSH Management Sciences for Health

NMRA National Medicine Regulatory Authority

NPMIC National Pharmacovigilance and Medicine Information Center

PHP

PTF

Public Health Program

Pharmacy Task Force

RFMA Rwanda Food and Medicines Authority

SOP Standard Operating Procedures

SPS Strengthening Pharmaceutical Systems [Program]

TB Tuberculosis

TRAC Treatment and Research AIDS Center

UMC The Uppsala Monitoring Centre

WHO World Health Organization


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INTRODUCTION

The need for monitoring medicines safety is globally recognized. Pre-marketing clinical trials for

the evaluation of quality, efficacy, and safety of new medicines provide the first opportunity for

generating data on the safety of a new medicine. However, pre-market clinical trials have many

limitations, including the relatively few number of patients exposed and lack of complete

understanding of long-term effects, co-morbid conditions, and use in the elderly, children, and

pregnant women, and among different racial groups. This means that when a new medicine is

released to the public, comprehensive understanding of its safety profile is incomplete.

Additionally, there have been increased efforts recently to expand access and introduce new

pharmaceutical products in developing countries. The Government of Rwanda (GoR) has

ensured access to these new pharmaceutical products for the management of HIV/AIDS,

tuberculosis (TB) and malaria. There is now a great need to compliment the efforts at expanding

access with adequate attention to rational use and safety monitoring. Monitoring safety during

real-life use can provide valuable safety information to compliment safety data generated during

pre-marketing clinical trials.

The need for safety monitoring may be particularly important in resource-constrained countries.

Adverse drug reactions (ADR) rank among the top 10 leading causes of mortality in several

developed countries;1 the overall incidence of serious ADRs from 1966 to 1996 was 6.7 percent

in the United States and the United Kingdom.2 The burden of ADRs in Rwanda is unknown;

however, it is projected that the burden may even be higher due to several factors including—

High prevalence of HIV/AIDS, TB, malaria and other co-morbid conditions

Insufficient knowledge of the quality of pharmaceutical products

Widespread use of traditional and complimentary medicines

Different genetic and nutritional status of Rwandese compared to those individuals who

participated in the clinical trials

Lack of capacity to monitor for early signs of toxicity

Pharmacovigilance and medicine information systems are therefore required in Rwanda.

Pharmacovigilance can provide useful information when characterizing and quantifying

previously recognized ADRs, determining actual effectiveness, identifying, and preventing new

drug-induced diseases early on, and reducing mortality and morbidity.

Traditional medicine use is increasing in the Western world (where it is not well regulated) and

is widespread in African countries. Several herbal medicines are used frequently, and may be

associated with adverse effects. Continuing vigilance is needed.3

1 Safety of Medicine -A guide to detecting and reporting adverse drug reaction- why health professionals need to

take action. http://apps.who.int/medicinedocs/en/d/Jh2992e/ 2 Lazarou, J, B. H. Pomeranz, and P.N. Corey. 1998. Incidence of adverse drug reactions in hospitalized patients: a

meta-analysis of prospective studies. Journal of the American Medical Association 279:1200-5. 3 The Uppsala Monitoring Centre (the UMC), WHO Collaborating Centre for International Drug Monitoring. 2000.

World Health Organization. 2000. Safety Monitoring Of Medicinal Products. Guidelines for Setting Up and

Running a Pharmacovigilance Centre. [in French]. Geneva: WHO.


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The Rwanda Ministry of Health (MoH) is committed to improving medicine safety monitoring

and protecting the public health. Guidelines and regulations are in place to ensure that the safety

and effectiveness of medicines available in Rwanda are monitored. It is the vision of the MoH

that all such related activities should be standardized and coordinated. These Guidelines for

Pharmacovigilance and Medicine Information System in Rwanda provide standard operating

procedures (SOPs) and directions for addressing all issues related to medicines and patient safety

in a comprehensive manner. Users are encouraged to regularly refer to these guidelines for

consistent understanding of medicine safety surveillance activities in Rwanda.

Establishment of the National Pharmacovigilance and Medicine Information Center To address the need of a system for routine medicine safety surveillance and to ensure the

protection of public health, the Rwanda MoH has established the National Pharmacovigilance

and Medicine Information Center (NPMIC). The NPMIC is based within the National Medicine

Regulatory Authority (NMRA) in the MoH. The NPMIC will fulfill its medicine safety role by

liaising with numerous MoH units, departments and committees.

Overarching goal of the NPMIC NPMIC’s goal is to develop and implement Pharmacovigilance and medicine information

systems that will provide unbiased information, monitor safety and effectiveness and improve

rational use of pharmaceutical products in Rwanda.

Scope of Pharmacovigilance and Medicine Information System in Rwanda The scope of activities grouped under Pharmacovigilance and medicine information undertaken

by NPMIC in Rwanda includes the following—

Monitor safety, effectiveness and tolerability of medicines used in Rwanda

Quantify and characterize occurrence of previously recognized ADRs in Rwanda

Conduct and coordinate spontaneous reporting and active surveillance activities

Provide unbiased medicine information to health workers and consumers

Monitor the promotion and advertising of all health products

Improve rational medicines use

Contribute to patient safety improvement

Develop interventions to reduce pharmaceutical product-induced morbidity and mortality

In addition, there are several MoH committees that are responsible for ensuring participation in

medicine safety surveillance activities, such as the selection of medicines for inclusion in the

standard treatment guidelines or the essential medicines lists. Information on safety, comparative


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effectiveness and rational medicines use greatly influence medicines selection activities like the

development of standard treatment guidelines, the clinical practice guidelines and the national

essential medicines list. The NPMIC is a national resource in providing evidence-based

information to influence medicines selection and related activities of technical committees in

Rwanda working in these areas.

Importance of Pharmacovigilance The World Health Organization (WHO) defines Pharmacovigilance as the science and activities

relating to the detection, assessment, understanding and prevention of adverse effects or any

other medicine-related problem. Recently, its concerns have been widened to include4—

Herbal medicines

Traditional and complementary medicines

Blood products

Biologicals

Medical devices

Vaccines

The information collected during the pre-marketing phase of drug development is inevitably

incomplete with regards to possible ADRs. This is mainly because—

Tests in animals are insufficiently predictive of human safety

In clinical trials, patients are selected and limited in number, the conditions of use often

differ from those in clinical practice and the duration of trials is limited

Information about rare but serious adverse reactions, chronic toxicity, use in special

groups (such as children, the elderly or pregnant women) or drug interactions is often

incomplete or not available

For all medicines, there is a tradeoff between the benefits and the potential to harm. To minimize

the harm, it is necessary that medicines of good quality, safety and efficacy are used rationally

and that the expectations and concerns of the patient are taken into account when therapeutic

decisions are made.


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Importance of Unbiased Medicine Information The provision of easily accessible and reliable unbiased information on medicines is an essential

element in achieving national health goals in Rwanda. Medicine information service is

committed to provide information to health care professionals, patients and/or consumers4 and

will be useful in the following situations—

Improving care and treatment outcomes

Ensuring that only evidence-based, consistent and locally peer-reviewed information are

provided to health workers and consumers

Providing health workers and consumers information on safety of medicines obtained

from credible sources

Educating health workers and consumers through trainings, written materials, and other

media activities

Monitoring medicine promotion and advertising activities to identify and address

spurious claims and misinformation

Conducting comparative effectiveness reviews

Providing pharmaceutical-related information to other MoH technical committees

involved in pharmaceutical products

4 U.S. Pharmacopeia. USP DQI Drug Information Program. (program title change, now known as ―Promoting the

Quality of Medicines‖). Available at http://www.usp.org/worldwide/PQMResourceLibrary.html

http://www.usp.org/worldwide/PQMResourceLibrary.html


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ADVERSE EVENT NOTIFICATION SYSTEM FOR PHARMACOVIGILANCE

An adverse event (AE) is any untoward medical occurrence that may present during treatment

with a pharmaceutical product but which does not necessarily have a causal relationship with the

treatment. An adverse drug reaction (ADR) is a response to a medicine which is noxious and

unintended, and occurs at a dose normally used in humans for prophylaxis, diagnosis or therapy

of disease; or for the modification of physiological function. This means that any ADR is

included in adverse event.

In Rwanda, the notification system focuses on detection of adverse events and the NPMIC

together with the Pharmacovigilance subcommittees in hospitals conduct causality assessment in

order to ensure that this event was really an ADR.

Reporting system

NPMIC activities rely heavily in regular interactions with healthcare providers and the

patients/consumers. Figure 1 shows the AE reporting system developed to guide the flow of

information for all the activities under the scope of the Pharmacovigilance system. A

Pharmacovigilance concern or a request for medicine information originates with the patient or

consumer. The patient/consumer is at the very foundation of the Rwandan reporting system. The

patient/consumer can report adverse events and/or request for medicine information through ant

healthcare provider present in health posts, health centers, private sector clinics and pharmacies,

hospitals and community health workers (CHW). All adverse events communicated by the

patient/consumer will be reported through an adverse event notification form filled in by

healthcare providers and collected by the respective hospital Pharmacovigilance subcommittees

(which serve as the hub for the implementation of Pharmacovigilance activities). The NPMIC

has collaborative responsibilities with several bodies including the public health programs and

the technical committees (for example, the standard treatment guidelines committees and the

pharmaceutical products list committee). The NPMIC reports to the NMRA which is accountable

to the MoH.


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Figure 1. Rwandan reporting system


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Roles and responsibilities in relation to Pharmacovigilance and Medicine Information It is important that all stakeholders, consumer organizations, civil societies and the public have

roles in monitoring safety and rational medicines use in Rwanda. The public are therefore

encouraged to participate in Pharmacovigilance activities through the channels of the notification

system. The roles and responsibilities of all bodies listed in the adverse event notification system

are listed below.

Patient/Consumer Patients/consumers have the following roles in medicine safety surveillance in Rwanda—

If a patient/consumer, family member, or someone the client knows experiences an

adverse event occurring during/after any medication or medical intervention, the event

should be reported to a healthcare provider

Request information from the healthcare providers within the health facilities or directly

from the NPMIC concerning any medicine

Report any suspicion of poor quality medicine to the community health workers, health

posts, health centers, hospitals, private clinics and pharmacies, or directly to the NPMIC

Healthcare providers including Community Health Workers

The healthcare providers provide the best quality care to patients. One of the responsibilities of

healthcare providers is to encourage patients to ask questions about their health condition and to

report adverse events. When patients report adverse events, healthcare providers have to manage

and report those adverse events.

Reporting these adverse events will provide valuable national data to be used by technical

committees and orient the regulatory decisions. Healthcare providers have the following roles

and responsibilities—

1. Provide advice to the patients on the need to adhere to the treatment plan and to report

any adverse event

2. Detect and manage adverse events and all health product-induced disorders

3. Report all adverse events to the NPMIC through Pharmacovigilance subcommittees

4. Participate in Pharmacovigilance activities in collaboration with the subcommittees

Note: In case of health products adverse events communicated to community health workers,

the workers have the responsibility to refer the patient to the health post/centre for further

care and report the event.


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PV Subcommittees Among the Drug and Therapeutics Committee (DTC) members, a subcommittee is appointed to

serve as the Pharmacovigilance subcommittee. This DTC subcommittee has to implement the

policies, guidelines and standards of the NPMIC. It has the following responsibilities—

Implement the Guidelines for Pharmacovigilance and Medicine Information System in

health facilities within its catchment area.

Ensure the availability of the adverse event notification forms and patient alert cards in

health facilities

Collect, validate and transmit all notifications to NPMIC

Ensure that healthcare providers are trained and familiar with the completion of the

notification forms and patient alert cards

Sensitize healthcare providers on Pharmacovigilance activities

Collaborate regularly with the NPMIC on Pharmacovigilance and medicine information

related issues

Identify and suggest interventions to address any medicine safety and/or irrational use

issues in health facilities within their catchment area

Public Health Programs The public health programs (PHPs) are sometimes requested to use new essential medicines. In

addition, PHPs which include mass treatment programs, do not have qualified healthcare

providers at community level. In these regards, public health programs are expected to be

sensitive to medicine safety issues. The PHPs, therefore, have the following responsibilities—

Collaborate with NPMIC to identify priority safety issues related to medicines used in

their programs

Collaborate with NPMIC to identify, plan and conduct active surveillance studies to

provide more information on safety issues related to medicines used in the program

Organize formal reporting of adverse events in mass treatment campaigns

Help increase awareness on the need to report adverse events for their particular products

and their transmission to the NPMIC

In collaboration with NPMIC, work with the Rwanda National Ethics Committee and

other related bodies to ensure proper review of study protocols


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Provide findings on all medicine safety-related studies to the NPMIC

Provide regular feedback to NPMIC on selected medicines safety indicators

Collaborate with NPMIC to provide regular trainings on Pharmacovigilance for health

care providers in the PHPs

Collaborate with NPMIC in using the standard operating procedures (SOPs) and

initiating active surveillance of the medicines they manage

NPMIC To fulfill the goal of developing and implementing the Pharmacovigilance and medicine

information system, the NPMIC has the following roles and responsibilities—

Provide technical advice to the MoH authorities in all policy decisions related to

medicine safety in Rwanda

Provide technical advice to the NMRA and other related bodies for decision making

Develop standards and procedures for Pharmacovigilance and medicine information

activities in Rwanda

Identify Pharmacovigilance and medicine information priorities and lead all efforts in

addressing them

Develop, implement and update tools for all Pharmacovigilance and medicine

information activities

Supervise all relevant Pharmacovigilance studies

Coordinate in-service Pharmacovigilance educational activities for healthcare providers

and consumers

Coordinate and provide technical support to PV subcommittees

Collaborate with the academic institutions and other stakeholders in providing pre-service

trainings in Pharmacovigilance

Provide medicine information to healthcare providers, patients/consumers and the entire

public through telephone, internet, media and publications

Conduct causality assessment on received adverse event notifications


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Serve as the secretariat of the National Medicine Safety Committee (NMSC)

Collaborate and participate in regional and international activities related to

Pharmacovigilance and medicine information

Collaborate with the WHO/Uppsala Monitoring Centre (the UMC) and other

Pharmacovigilance centers to exchange information and data related to medicine safety

Establish formal ways of collaboration with all stakeholders in all issues related to

Pharmacovigilance and medicine information

NMRA

The NMRA oversees the functioning of the NPMIC and has the following responsibilities—

Supervise the implementation of the national Guidelines for Pharmacovigilance and

Medicine Information System

Identify knowledge and gaps in Pharmacovigilance and collaborate with the NPMIC to

address them

Propose to MoH the decisions to be taken to improve medicine safety surveillance and

information.

NMSC The National Medicine Safety Committee serves as an expert advisory committee to the Ministry

of Health for Medicine safety, effectiveness and quality issues. It is a multidisciplinary

committee composed of specialized individuals appointed by the Ministry of Health (MoH).

The NMSC has the following responsibilities:—

• Advise on Medicine registration issues related to safety, effectiveness and quality;

• Provide technical advice to the National Pharmacovigilance and Medicine Information

Center (NPMIC) in causality assessment and/or analysis on medicine adverse events.


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Other Stakeholders

Marketing Authorization Holders

Marketing authorization holders (MAHs) in Rwanda include the holder of the registration

certificate, the local representative of the manufacturer (distributor or wholesaler), the importer

of the product and all other persons who obtained permission from the NMRA to manufacture,

import and market pharmaceuticals in Rwanda. Each MAH has the following responsibilities

towards medicine safety surveillance in Rwanda—

Mandatory reporting of all adverse events associated with the product the holder is

authorized to distribute, including those events that are not detected in Rwanda. MAHs

are responsible to report all such adverse event reports that they are informed of to the

NPMIC. Serious adverse events should be reported within 48 hours of the receipt of such

reports, while non serious events should be reported within 15 days of the receipt of the

report. The MAH can use the NPMIC notification form for the purpose of this report

The MAH is expected to provide all medicine safety relevant information related to his or

her authorized product to the NPMIC every three months

The MAH who intends to promote and advertise products or provide sponsorships should

adhere to the regulation in place.

MAHs should collaborate with the NPMIC toward conducting post-authorization safety

studies as identified by relevant authorities in Rwanda

There are many stakeholders that will need to be involved in the national Pharmacovigilance and

medicine information system at different levels, such as qualified health professionals,

researchers and academic institutions, media, procurement agencies, standardization institutions,

funding and technical assistance partners, and international and regional health organizations.

UMC/WHO The UMC’s responsibilities in regards to the national Pharmacovigilance centers, including the

NPMIC, are globally the same.

Receive and store reports from national Pharmacovigilance centers

Provide tools, trainings and access to information systems to enable national

Pharmacovigilance centers to search the global WHO database

Monitor signals from the global WHO database (a signal refers to ―reported information

on a possible causal relationship between an adverse event and a drug, the relationship

being unknown or incompletely documented previously.‖)


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Communicate signal analyses to national Pharmacovigilance centers and clinical review

of the analyses by experts

Provide technical assistance to national Pharmacovigilance centers

Facilitate communication between countries

Develop and maintain WHO Adverse Reaction Terminology and the use of the Medical

Dictionary for Regulatory Activities within the WHO International Drug Monitoring

Program

Train national Pharmacovigilance centers’ staff

Standardize procedures relating to Pharmacovigilance activities

Publish relevant documents

Provide data as appropriate to other parties

A signal refers to “reported information on a possible causal relationship between an

adverse event and a drug, the relationship being unknown or incompletely documented

previously.” Usually more than a single report is required to generate a signal,

depending upon the seriousness of the event and the quality of the information.


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MEDICINE INFORMATION

Literature scan for relevant safety alerts

The NPMIC shall provide unbiased and evidence-based medicines information to health care

professionals, consumers and the public. Appropriate medical literature will be routinely scanned

for relevant safety alerts which will then be communicated to stakeholders.

Risk communication The NPMIC shall communicate the risk related to medicine safety guided by the risk

communication manual for medicine safety.

Requesting medicine information

Healthcare professionals, consumers and the public should request medicine information from

the NPMIC. Medicine information provided by the NPMIC should be independent and evidence-

based. The NPMIC should establish a quality assurance system to ensure that quality medicine

information is provided.

Information, Education, Communication Materials and NPMIC Publications The NPMIC shall routinely produce relevant information, education, communication materials to

meet its objective towards providing quality, relevant and evidence-based medicine information.

The NPMIC shall maintain a regular publication of medicine information and medicine safety

bulletin or newsletter.

Medicine Promotion and Advertising

All medicine promotion and advertising activities shall be conducted with a primary aim of

promoting public health and according to the regulations in place. The NPMIC shall notify the

competent authority of any medicine promotion and advertising activities that can negatively

impact on patient and medicines safety.

The national guidelines for promotion and advertising of pharmaceutical products shall be

adapted by the NMRA with guidance from the WHO ethical criteria.


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PHARMACOVIGILANCE METHODS

The classic Pharmacovigilance system relies on5—

Passive surveillance: This applies to the entire population and monitors any adverse

events that occur in any patient. Among its weaknesses, there are lack of solid

comparisons (target and subject of the surveillance) and the inaccuracy of reporting in

addition to the low rate of occurring events. It generates signal/alert that active

surveillance could use for further investigations.

Active surveillance: This method uses the pharmaco-epidemiological methods to

overcome the limitations of the passive Pharmacovigilance. Based on the signal/alert

generated by passive surveillance, it helps to identify the subject of surveillance and

applies an appropriate methodology that will allow the causality assessment of adverse

event. Its main weakness is its high cost in addition to its limited number of subjects.

MAH surveillance: Once a product is authorized to be on the market, the MAHs are

requested to continue to closely monitor their product’s safety to contribute post

marketing surveillance. This surveillance combines both passive and active surveillances

and it is initiated by the MAHs without any direct participation of the NPMIC.

Passive surveillance is the principal method adapted to limited resources settings like Rwanda.

As spontaneous reporting is known as the basic mechanism of this surveillance, it is the main

method to be used in generating signals/alerts of adverse events for further investigations.

Spontaneous Reporting Spontaneous reporting involves the submission of unsolicited adverse event reports to NPMIC.

This is useful for identifying safety signals of rare adverse reactions and generating hypotheses.

It provides critical information that is in identifying patients who are at risk of an adverse effect

to a medicine. It also can give more information on real-life experience with a medicine beyond

data obtained from clinical trials.

Spontaneous reports are usually submitted in standardized notification forms that include four

key fields—patient identification, adverse event, suspected product and details on the healthcare

professional who produced the adverse event report. Other details, however, must also be

reported to help the causality assessment like allergies to medications, other risk factors, etc.

Spontaneous reports can be used for to the reporting of all known and undocumented (unknown)

adverse events, serious or not. These events could be the consequences of medication errors,

drug interactions, therapeutic ineffectiveness, product quality problems, and problems with

medical devices even if there is no obvious relationship between the event and the suspected

product. It is important to send spontaneous reports to the NPMIC promptly.

5 WHO. 2002. Safety of Medicines. A guide to detecting and reporting adverse drug reaction; why health

professionals need to take action. Geneva: WHO. http://whqlibdoc.who.int/hq/2002/WHO_EDM_QSM_2002.2.pdf


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Spontaneous Reporting in Product Quality Monitoring Spontaneous reporting is a routine and cost-effective way of monitoring product quality

problems at the national level. A notification form has been developed to allow institutions and

health care professionals to alert the Regulatory Authority of problems encountered with the

medicines supplied to or used by them. This important information help the safety monitoring of

medicines and, in addition to notifying NPMIC, the information goes to other departments in the

regulatory authority such as the registration department, inspection department, and the quality

control (laboratory analysis) department. The form has been designed to incorporate the most

common pharmaceutical problems encountered.

In Rwanda, even though the submission of spontaneous reporting shall be voluntarily done by

healthcare professionals, they are encouraged to report all adverse events brought to their

attention. Moreover, it is mandatory to report any serious adverse event which caused—

Death

Life threatening conditions

Disability

Congenital anomaly

Hospitalization

Modification of therapy due to toxicity

The submission of spontaneous reports of suspected adverse events should be guided by the

following—

In-time reporting

o Report any suspected adverse drug reaction as soon as it occurs

Accuracy and completeness

o Each notification form must accurately and legibly be filled out with all the necessary

information that is available. This is very important during causality assessment. The

minimum information that is required include—

Patient identification

Detailed adverse event

Details on the suspected pharmaceutical product,

Identification of the person who has completed the adverse event notification

form

In some emergency cases, reporters can also directly contact the NPMIC to inform them

about any adverse event occurred to their premises. The NPMIC will then complete a

notification form on their behalf. Reporters are encouraged to have complete information

ready at the time they are contacted by NPMIC for more details.


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Two types of notification forms have been developed to capture reporting related to

adverse event and poor quality medicines.

o The notification form for the reporting of all adverse events in patients exposed to a

medicine or device in Rwanda is attached to these guidelines (annex A [French];

annex B [English]) and will be available at health facility level. Electronic forms can

also be obtained from the MoH website (http://www.moh.gov.rw).

o The notification form for the reporting of all poor quality problems in health facilities

or at patient level in Rwanda is attached to these guidelines (annex C [French]; annex

D [English]) and will be available at health facility level. Electronic forms can also be

obtained from the MoH website (http://www.moh.gov.rw).

Emergency cases and lack of forms

o As mentioned above, in some emergencies, reporters can also directly contact the

NPMIC to inform them about any adverse event that occurred on their premises.

Who Should Report?

All health professionals

Community health workers

Patients, patients’ relatives

Public in general

The Rwanda notification system also allows traditional medicine practitioners and the public at

large to report all adverse events related to the use of any health product to the NPMIC through

Pharmacovigilance subcommittees. Such health products may include complementary and

alternative medicine and nutritional and dietary supplements.

Where to Report?

To healthcare providers in health facilities

To Pharmacovigilance subcommittee of drug and therapeutics committee in hospital

To the NPMIC

How to Report Adverse Events

A patient who has experienced the adverse event should report to the nearest healthcare

provider.

At health center level, the head of health center is responsible of collecting the completed

adverse event notification forms and sending them to the DTC secretariat of the nearest

district hospital

http://www.moh.gov.rw/



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At the hospital level, the healthcare providers should fill a notification form and give it to

their chief of service who forwards it to the Pharmacovigilance subcommittee at their health

facilities within the defined time

The Pharmacovigilance subcommittee validates the collected forms before sending them to

the NPMIC within the defined period of time

Once the notification form is submitted and received, there shall be a delivery note from the

receiver.

How to Report Poor Quality Medicine Problems

Any patients, healthcare professionals, or anyone else who notices/suspects a poor quality

medicine should report it to the nearest healthcare provider by—

o Filling the notification form

or

o Reporting the poor quality by any other means than notification

At health center level, the head of health center is responsible of collecting the filled poor

quality medicine notification forms and sending them to the hospital management which will

orient them to the PV subcommittee

At the hospital level, the healthcare providers should fill a notification form and give it to

their chief of service who forwards it to the Pharmacovigilance subcommittee at their health

facilities within the defined time

The PV subcommittee should validate the collected forms before sending them to the

NPMIC within the defined period of time

Once the notification form is submitted and received, there shall be a delivery note from the

receiver.

What Should Be Reported?

Report all suspected adverse events to medicines, traditional/herbal medicines, X-ray contrast

media, medical devices, cosmetics, nutritional and dietary supplements, and other health

products which are not mentioned here.

In addition to the ADR, report medicine quality problems noticed at patient level such as—

o Color change

o Separation of components

o Powdering/crumbling

o Caking

o Molding

o Change in smell

o Poor packaging

o Poor labeling and mislabeling

o Suspected contamination

o Questionable stability

o Defective components

o Expired medicines


22

When to Report?

Serious adverse events should be reported immediately to the NPMIC or its decentralized

unit as they occur or as the reporter learns about them. When those reports are sent to the PV

subcommittees, those units are requested to transmit them to the NPMIC without any delay.

The notification form for serious adverse events must be filled within 24 hours and sent to

the NPMIC within 48 hours from the time of notification.

Serious adverse events must be reported to the head of clinical services in the health facility

before being sent to the NPMIC

Other adverse event reports should be received at NPMIC not later than one month after they

have been reported to the health facility.

Poor quality medicine should be reported as soon as possible, it follows the same scheme as

the adverse events.

What Happens to a Report?

The submitted report is validated and entered into the national database of adverse events.

This database enables the NPMIC to keep track of all adverse event reports received

nationwide.

o For adverse event, the reports are routinely analyzed using the WHO and French methods

as they are received and documented in a standard format for the determination of

causality by the NPMIC.

o For poor quality medicines, the reports are analyzed by a team composed by

representatives of the Medicine Inspection, Medicine Registration services, NPMIC staff,

Rwanda Bureau of Standards and laboratory of medicine analysis.

The information obtained from these analyses will be submitted to the NMRA to help the

MoH in decision making. NPMIC will disseminate conclusions from analysis reports and

related decisions through existing communication channels.

The NPMIC will regularly send—

o Analyzed adverse event notifications to the UMC

o Analyzed notifications of poor quality medicines to inspection, registration, and lab

analysis department for further actions


23

A well-completed and duly submitted adverse events and poor quality medicine notification

form by a health professional may result in—

o Additional investigations into the use of the medicine in Rwanda

o Appropriate changes of the package and notice

o Changes in the ways of using the pharmaceutical product

o Enhancing educational initiatives to improve the safe use of that medicine

o Other regulatory and health promotion interventions as the situation may warrant

including product withdrawal/recall

How Do the Healthcare Provider and Patient Benefit from Reporting? The healthcare provider and patient benefit from reporting through—

Improved quality of care offered to patients

Reduced medicine-related problems leading to a better treatment outcome

Improved patient confidence in professional practice, hence professional growth

Improved knowledge

Access to feedback information on medicine-related problems reported within the

country and internationally

Satisfaction in fulfilling a moral and professional obligation

Use of Spontaneous Reporting in Medication Error and Patient Safety Monitoring The notification form in Rwanda contains fields for the documentation of medication errors

occurred simultaneously with an adverse event. The NPMIC shall monitor medication errors and

assess their root causes to contribute in improving patient care. The NPMIC will use an updated

version of the US National Coordinating Council for Medication Error Reporting and Prevention

index for categorizing medication errors.

Protection of the Healthcare Professionals Who Report Adverse Events

Reporting an adverse event does not necessarily mean that the healthcare professional or the

medicine has contributed to or caused it.

The outcome of the notified adverse event will be communicated to the healthcare provider

who reported the case.

The information given in the notification form is strictly confidential up to the central

database level.

The information obtained from reports will not be used for commercial purposes, but is

intended to improve the rational use of pharmaceutical products.


24

Active Surveillance

The spontaneous reporting system remains the backbone of medicine safety monitoring in

Rwanda. Active surveillance methods can be used in further validating spontaneous report

signals generated through the NPMIC spontaneous notification system. However, because of the

known limitations of spontaneous reporting including the lack of denominator data, lack of

controls, poor case documentation, and the inability to ascertain the report’s validity, the NPMIC

should promote conducting relevant active surveillance studies in Rwanda. The overall

responsibility for the monitoring of active surveillance studies and other pharmacoepidemiology

studies remain the prerogative of NPMIC.

6 International Society for Pharmacoepidemiology. 2008. Guidelines for Good Pharmacoepidemiology Practices,

GPP. Pharmacoepidemiology and Drug Safety 17: 200–208.

7 WHO. 2006. The safety of medicines in public health programmes: Pharmacovigilance an essential tool. Geneva:

WHO. http://www.who.int/medicines/areas/quality_safety/safety_efficacy/Pharmacovigilance_B.pdf.

8 WHO. 2007. Pharmacovigilance for antiretrovirals in resource-poor countries. Geneva: WHO.

http://www.who.int/medicines/publications/PhV_for_antiretrovirals.pdf

General Guidelines for Conducting Pharmacoepidemiological Studies

In general, local and international experts and organizations interested in conducting

pharmacoepidemiology studies in Rwanda will require formal technical approval from the

NPMIC in addition to the Rwanda National Ethics Committee and the NMRA approval for the

study to take place. Researchers are also advised to review and, as much as possible, comply

with the guidelines for good pharmacoepidemiology practices6 and related WHO

publications.7,8

These guidelines recommend the following when conducting these studies—

All pharmaco-epidemiology study proposals should be submitted to the NMRA which

will then set research priorities and ensure that the following issues are clearly

identified—

o Study objectives

o Active surveillance method

o Capacity to implement method

o NPMIC Involvement

There should be a detailed protocol developed for the study.

Responsibilities and plans to ensure compliance to national ethical standards should be

clearly stated

Protocol should be approved by the ethical committee.

Research findings should be reviewed and approved before publication by the NMRA.

http://www.who.int/medicines/areas/quality_safety/safety_efficacy/Pharmacovigilance_B.pdf

http://www.who.int/medicines/publications/PhV_for_antiretrovirals.pdf


25

Some active surveillance methods used in Rwanda

To implement plans for routine active surveillance activities, the NMRA will ensure that SOPs

are in place for conducting active surveillance studies. After identifying research priorities, the

authority will provide technical guidance on the preferred active surveillance method to be used.

The following active surveillance methods can be used—

Cohort event monitoring

Case control studies

Prescription event monitoring

Medicine/device exposure registries

Medicine utilization studies

The PHPs can identify their research priorities based on prevalence, frequency and importance of

ADR spontaneous reports related to their specific products. They should therefore regularly

collaborate with the NPMIC and identify important signals that may require validation using

active surveillance methods.


26

SAFETY MONITORING OF HERBAL MEDICINES IN THE NATIONAL PHARMACOVIGILANCE SYSTEM

In developing countries, some herbal medicines are considered to be more readily available,

accessible, affordable, culturally acceptable and sustainable than Western medicines. In

developed countries, the popularity of herbal medicines continues to grow, particularly for

treating certain disease categories.

However, herbal medicines are not necessarily always safe simply because they are natural.

Some have given rise to serious adverse reactions and some contain chemicals that may produce

long-term side effects such as carcinogenicity and hepatotoxicity. Herbal medicines will only

benefit the health of human beings when they are used appropriately. Thus, good quality control

and standardization of herbal medicines are essential. Furthermore, with the increased use of

both herbal medicines and modern western pharmaceutical drugs, there is a need to monitor

interactions.

Reporting adverse events related to herbal medicines shall be the same as for the other health

products mentioned in this guideline and shall involve cooperatives made up of traditional

healers that are officially approved by the appropriate authorities.

The national policy on traditional and herbal medicine as well as related guidelines shall be the

referral and support documents.


27

TOOLS FOR MEDICINE SAFETY SURVEILLANCE ACTIVITIES

Pharmacovigilance activities involve the use of several validated tools to generate and analyze

data to guide decisions. In an effort to standardize all Pharmacovigilance and medicine

information system processes in Rwanda, the following tools have been developed and adopted

for key activities of the NPMIC. These tools can be revised if needed.

Adverse event notification form The Adverse Event Notification Form (annex A–French; annex B–English) is the official tool by

which all suspected adverse events shall be reported. It is designed to be short, simple, and easy

to complete. The notification form collects important details pertaining to the suspected adverse

events. The form should be used for the following events—

All suspected adverse events related to the use of medicines and medical devices

All suspected adverse events related to the use of complementary and alternative

medicines, traditional/herbal medicines, and cosmetics, nutritional and dietary

supplements

Poor quality medicine notification form The poor quality medicine notification form (annex C–French; annex D–English) is the official

tool by which all suspected poor quality medicines shall be reported. It is designed to be short,

simple and easy to complete. The notification form collects important details pertaining to the

poor quality medicine. The form should be used for the following—

o Color change

o Separation of components

o Powdering/crumbling

o Caking

o Molding

o Change in smell

o Poor packaging

o Poor labeling and mislabeling

o Suspected contamination

o Questionable stability

o Defective components

o Expired medicines


28

Medicine information request form The medicine information request form (annex E) is the official tool in Rwanda for making

requests to the NPMIC for information related to medicines or health products and related

pharmacotherapy issues. The scope of what can be included in a request for medicine

information is—

Mode of administration and dosage

Indication and choice of therapy

Interactions (drug-drug, drug-disease, etc.)

Adverse effects and toxicities

Management of poisoning

Product identification, packaging, labeling

Product manufacturer and availability

Medicine utilization data

Disease profile and management

Recent evidence and studies on specific diseases and medicines

Epidemiology of diseases in Rwanda

Any other related questions

Requesting for medicine information can also be through phone calls and e-mail messages.

Clients are requested to clearly specify what information they seek so that they can receive

answers that precisely answer their questions. The NPMIC has developed standard tool for

providing responses to the enquirer.

Causality assessment tool After adverse event reports are received, the NPMIC works closely with the NMSC to determine

causality between the reported event and the health products the patient or consumer has been

exposed to. There are several scales for determination of causality. In Rwanda, the NPMIC uses

the WHO causality assessment criteria as the official reference for deciding on the contribution

of the health product to the adverse event. The criteria are classified as Certain, Probable/Likely,

Possible, Unlikely, inaccessible/unclassified and conditional/unclassified. The WHO causality

assessment criteria tool is attached as annex F.

Adverse event severity grading scale When adverse events are reported in Rwanda, the severity of the event will be determined

through an evaluation of the report, medical records and further discussions with the reporter.

Understanding of the severity of adverse events will guide the decisions about adverse events

that are of importance for further studies in Rwanda. It will also provide information for the

education of healthcare workers on adverse events and their management. In Rwanda, the WHO

toxicity grading scale for determining the severity of adverse events will be the official reference

for the grading of severity of adverse events. The tool is attached as annex G.


29

Medication error assessment tool When medication errors are identified and reported, there are opportunities for learning from the

experience and preventing further errors. The NPMIC provides advocacy and resources for the

monitoring and learning from medication errors and patient safety problems. In Rwanda, the

American National Coordinating Council for Medication Error Reporting and Prevention Index,

(NCC MERP) will be the reference for grading medication errors in Rwanda. The NCC MERP

index is attached as annex H.

Patient Alert Card The Patient Alert Card notifies all healthcare providers that its bearer has experienced some

serious intolerance (typically hypersensitivity reactions) to a particular medicine. This will help

them to identify the patient's medicine-related intolerence and prevent the same (or similar)

medicine reactions. The card is expected to be carried by the patient all the time and must be

presented to healthcare providers during consultation or dispensing time . The Patient Alert Card

for official use in Rwanda is attached as annex I (annex J is Patient Alert Card in Kinyarwanda).

This card will be delivered by the DTC/PV subcommittee and inform the NPMICfor registration.

Glossary of medicine safety terms

To ensure common understanding of all terms used in medicine safety surveillance activities in

Rwanda, standard official definitions as applicable to Rwanda have been provided for relevant

Pharmacovigilance and medicine safety terminologies. Users are encouraged to review these

terms and use them in the same definition and meaning as it has been provided in this document.

The official glossary of medicine safety terms are provided as annex K.

All health care workers are encouraged to use these tools as indicated and continuously provide

positive criticisms on their improvement to the NPMIC. The NPMIC, in consultation with

various stakeholders, will review these guidelines and tools periodically, to ensure that they

continue to meet the goals of Pharmacovigilance and medicine information activities in Rwanda.


30

CAPACITY BUILDING

Staff members working at health facilities require continuous capacity building activities on

Pharmacovigilance. ADRs are not well understood and, in many countries, are seldom detected.

Attention to monitoring also may be neglected, and thus staff members need to stay aware that

ADR monitoring is part of their good clinical practices. Trainings are required to ensure that staff

members understand prescribing practices for new medicines, the correct dosage regimen and

how treatment failures are managed. Staff members also need to be taught how to detect ADRs,

where to refer the patients and how to complete the ADR reporting form accurately. In addition,

continuous clinical guidance for improved recognition of adverse reactions is required. Staff will

need to feel confident and motivated in reporting while assisting the NPMIC in its mission.

Common concerns and barriers to reporting by healthcare personnel will be addressed in such

capacity building activities.

The MoH, through technical assistance of SPS, has developed the National Curriculum and

Training Module for Pharmacovigilance. The purpose of this training is to equip all healthcare

workers across the healthcare delivery system with the necessary skills, knowledge, and attitudes

that will enable them to effectively identify, assess, and report ADRs; and take appropriate action

to improve medicine safety. The trainings started with a training of trainers limited to a small

number of healthcare providers, essentially doctors and pharmacists, who will be subsequently

called upon to conduct the national training for selected DTC members at the hospital level. With

the support of training of trainers’ core group, NPMIC supervised service trainings throughout

the country at district level, using the trained DTC members as trainers in their respective health

facilities.

The NPMIC routinely coordinates any other capacity building activities at national and hospital

level to ensure the correctness and relevance of the delivered information while avoiding

unnecessary dispersion of efforts. On the other hand, in order to enable NPMIC and NMSC to

conduct causality assessment and analysis, there is a need to deeply capacitate the respective

members on different pharmaco-epidemiologic methods.

MONITORING AND EVALUATION

For effective Pharmacovigilance and medicine information activities in Rwanda, the NMRA

shall identify some performance measures for monitoring Pharmacovigilance activities of both

NPMIC and the PHPs. These performance measures include indicators, reports and performance

targets that will be routinely reported to the NMRA.


31

ANNEXES


32

ANNEX A. ADVERSE EVENT NOTIFICATION FORM

A.1. FRENCH VERSION:

FICHE DE NOTIFICATION DES EVENEMENTS INDESIRABLES

Centre National de Pharmacovigilance Et d’Information Pharmaceutique

FICHE DE NOTIFICATION DES EVENEMENTS INDESIRABLES A. Informations sur le patient Adresse du patient Village : Secteur

Cellule : District

Autres adresses disponibles (téléphone/email)

No d’identification du patient (N0 fiche, consultation, etc.)

Date naissance ...……/..……/..…… ou Age …………………………

Poids (Kg) Taille (en cm) Sexe

F

M

Grossesse ? Oui Non Pas Connu Si oui, âge gestationnel (en Semaine d’aménorrhée):

La femme enceinte est : Primipare Multipare

Le patient a-t-il une (des) maladie(s) chronique(s) ? Oui Non Pas connu Si Oui, lesquelles (compléter si nécessaire)

1

2 3 4

Facteurs de risque associés (encerclez): tabac, alcool, l’histoire clinique du patient, antécédent familial, les allergies, …). Décrivez les autres facteurs associés s’il y en a (ajouter une feuille supplémentaire si nécessaire):

B. Informations sur les événements indésirables qui pourraient être dus au produit de santé Description de l’événement indésirable :

Date et heure de début de réaction ….. /…../….. à …..h……

Délai d’apparition de la réaction (en heures/jours): ……………………………….

Date et heure d’arrêt de réaction si applicable …../…../….. à …..h……

Information sur le produit de santé suspecté

Nom générique du produit ou nom vernaculaire, forme et dosage :

Nom de la spécialité/fabricant :

Date de fabrication : Date d’expiration : No de Lot/batch No :

Le produit est il prescrit ? Oui Non Pour quelle raison le produit a-t-il été prescrit (indication) :

Dose Prescrite : Fréquence prescrite : Durée du traitement Dose prise : Fréquence de prise par jour :

Date/si possible heure de début de prise du produit :

Date/ si possible heure d’arrêt de prise du produit :

Voie d’administration utilisée par le patient : Détails sur la dilution (si applicable) :

Où est-ce que le patient s’est-il procuré le produit ?

Est-ce la première fois que le produit suspecté est pris ? Oui Non. Si Non, l’effet était-il apparu auparavant Oui Non

Y a-t-il eu des mesures prises pour gérer/traiter l’événement indésirable ? Oui Non

Si oui, spécifier les moyens utilisés pour gérer l’effet indésirable observé (traitement médicamenteux, référence, arrêt du traitement, conseils, changement de traitement,…)

Evolution de l’événement indésirable

Guérison sans séquelles Pas encore guéri

Hospitalisation Prolongation d’hospitalisation

Mise en jeu du pronostic vital Incapacité permanente

Décès Pas connu

autre : spécifier

REPUBLIQUE DU RWANDA

MINISTERE DE LA SANTE


33

C. Autres produits utilisés Y a-t-il d’autres produits utilisés par le patient ? Oui Non. Si oui compléter le tableau ci-

dessous (Ajouter une feuille supplémentaire si nécessaire)

D. Informations sur le notificateur Nom et Prénom *

Qualification * : Lieu de travail /FOSA*

Adresse postale* : Téléphone du lieu de travail/FOSA *

Email : Date*

Que peut vous apporter le CNPIP ?

Le CNPIP est au service de tous les professionnels de santé tant du secteur public que privé pour :

Recueillir et analyser toute suspicion suggérant un effet indésirable dû à un produit de santé afin

d’établir la relation de cause à effet

Répondre aux questions relatives à l’utilisation des produits de santé

Evaluer les risques d’une exposition aux produits de santé chez les personnes à haut risque

Diffuser les informations sur la Pharmacovigilance aux professionnels de santé, aux

patients/consommateurs et au grand public

Notification des effets indésirables au CNPIP La Pharmacovigilance a pour objet la détection, l’évaluation et la prévention des effets indésirables de

tout produit de santé survenant dans une population.

Les produits de santé concernés par cette notification sont :

Les produits pharmaceutiques

Le sang et ses dérivés

Autres produits de santé notamment les produits alimentaires et cosmétiques, ainsi que les

produits biologiques tels que les cellules humaines, les tissus, et les produits à base de cellules ou

de tissus.

Qui doit notifier?

Tous les professionnels de santé

1 2 3

Nom du produit

Indication

Posologie utilisée par le patient

Voie d’administration telle que utilisée par le patient

Date (et si possible heure) de début

Date (et si possible heure) d’arrêt

Votre appui au système de Pharmacovigilance est grandement apprécié.

La soumission d’une plainte n’implique en aucun cas que le médicament ou le prestataire des soins ont causé ou contribué à l’apparition de cet

événement. Toute information est strictement confidentielle et le personnel du système de Pharmacovigilance ne mettra jamais en public l’identité

du rapporteur/notificateur en réponse à une quelconque demande publique. L’information que vous fournissez contribuera à l’amélioration de la

qualité des soins et la sécurité d’utilisation du médicament.

Une fois remplie, veuillez envoyer cette fiche au Centre National de Pharmacovigilance (CNPIP) ou au sous comité de Pharmacovigilance de

l’hôpital qui vous est proche.


34

Que faut-il notifier ?

Tout événement indésirable, clinique ou biologique, observé chez un patient et coïncidant avec

l’exposition à un produit de santé, connu ou non connu, grave ou bénin.

Comment notifier ?

La notification du cas doit se faire sur cette « fiche de notification des effets indésirables » du

Ministère de la Santé.

La notification du cas peut se faire par :

o Courrier : BP 84 Kigali

o E-mail : [email protected]

[email protected]

o Site web : www.moh.gov.rw

Veuillez noter que :

La notification du cas se fait même si vous n’êtes pas sûrs que ce soit le produit suspecté qui est à

la base de l’effet indésirable ou quand vous n’avez pas suffisamment de données.

La soumission d’une fiche de notification n’implique pas automatiquement que le professionnel

de santé ou le produit a causé ou contribué à l’apparition de l’effet indésirable.

La fiche de notification remplie doit être acheminée vers le niveau supérieur endéans 48 heures

Toutes les informations rapportées sur cette Fiche sont strictement confidentielles.

Les informations sur le notificateur qui sont accompagnées du signe * sont obligatoires.

Pour les sites ART, le dispensateur des soins identifiera le patient par son code TRACNET.

mailto:[email protected]

mailto:[email protected]



35

A.2. ENGLISH VERSION:

ADVERSE EVENT NOTIFICATION FORM

National Pharmacovigilance and Medicine Information Center

ADVERSE EVENT NOTIFICATION FORM

A. Patient Information Patient address Village : Sector:

Cell : District:

Other available address (cell phone/email,…)

No of patient file/dossier Date of birth ...……/..……/..…… or age …………………………

weight (Kg) height( cm) Sex F M

Pregnancy? Yes No Don’t know

If yes, indicate the length of pregnancy in weeks (amenorrhea weeks):

The pregnant woman is : primiparous multiparous

Does the patient have any chronic diseases? yes No don’t know If yes, list those diseases (diabetes, tuberculosis) in the following areas (you can add another paper if needed)

1

2 3 4

Associated risk factors (tick on the following ones): tobacco use, alcohol use, clinical background, familial history, allergies … Describe any other risk factors if applicable (you can add another paper on this if needed):

B. Information on adverse events related to suspected health product Description of the adverse event :

Date and time of when adverse reaction started ….. /…../….. at ……h…… min

Time to onset of reaction (hours/days): ……………………

Date and time when reaction stopped …../…../….. at …..h……min

INFORMATION ON THE SUSPECTED HEALTH PRODUCT

Name of the product in INN or local name ( if plant medicine), form and dosage :

Brand name/manufacture :

Manufacture date : Expiry date : Batch No :

The product was prescribed? yes No

If the product was prescribed, indicate the reason why :

Dosage Prescribed : Frequency of daily dosing prescribed : Treatment duration : Dosage taken : Frequency of daily dosing use by patient:

Date, if possible time of the starting taking the suspected product:

Date, if possible, the time the suspected product was stopped:

The administration route used by patient : Details on the dilution (if applicable) :

Where patient got this product from?

Is it the first time the patient has taken the suspected product? yes No. If no, did he experiment the same reactions the last time he/she took this product? yes No

Is there any measure taken to manage /treat this adverse event? yes No

If yes, indicate these measures (pharmaco-therapy, refer the patient, stop the treatment, change the treatment, etc….)

Evolution of adverse event

Recovery without sequelae Not recovered yet

Hospitalization Prolonged hospitalization

Life threatening Permanent incapacity

Deceased Unknown

others : specify

REPUBLIC OF RWANDA

MINISTRY OF HEALTH


36

C. Other products used: Is there any other product used by patient? Yes No. If yes, fill the table below (Add a new page if needed)

1 2 3

Name of the Product

Indication

Dosage used by patient

Administration route used by patient

Date (time if applicable ) of start to take the product

Date (time if applicable) of stop to take the product

D. Information on the notificator Name *

Qualification * : Place of Work/Health Facility*

PO box* : Phone number/yours or for the Health Facility*

Email : Date*

Your support in this Pharmacovigilance program is appreciated.

Submission of a complaint does not constitute an admission that medical personnel or manufacturer or the product caused or contributed to the event. All information is held in strict confidence and programme staff is not expected to and will not disclose reporter/notificator’s identity in response to any public request. Information supplied by you will contribute to the improvement of medicine safety and therapy in Rwanda. Once completed please send to: National Pharmacovigilance and Medicine Information Center (NPMIC) or to the Drug and

Therapeutic Committee (DTC) of the nearest hospital.


37

ANNEX B. POOR QUALITY MEDICINE NOTIFICATION FORM

B.1. FRENCH VERSION:

FICHE DE NOTIFICATION SUR LA QUALITE DES MEDICAMENTS

CENTRE NATIONAL DE PHARMACOVIGILANCE ET

D’INFORMATION PHARMACEUTIQUE

FICHE DE NOTIFICATION SUR LA QUALITE DES MEDICAMENTS

A. Informations sur le rapporteur Veuillez cochez la case suivante selon votre statue

1. patient 2. Professionnel de la santé 3. autres : spécifier :

Date de la notification : ……….J/……..M/………A

Adresse du rapporteur

Village : Secteur

Cellule : District

Autres adresses disponibles (téléphone/email, lieux de travail, etc…)

Le rapporteur a-t-il pris le médicament Oui Non

B. Identification du produit Nom de spécialité Nom générique

Numéro de lot Date de fabrication Date de péremption

Date d’acquisition/achat Nom du producteur et son pays d’origine

Nom du fournisseur (hôpital, pharmacie, etc..)

Adresse du distributeur

FORMULATION DU PRODUIT (cocher le cas

échéant)

PLAINTES A L’ENCONTRE DU PRODUIT (cochez le

cas échéant)

Comprimé Oral/Capsule Suspension buvable Sirop Injection Poudre pour reconstitution d’une suspension Poudre pour reconstitution d’une injection Gouttes nasales Gouttes Oculaires Solution nébuliseur Crème/ gel/pommade Autres :…………………………………………………

Changement de couleur Agglomération/ grumeaux Visqueux (formes solides) Changement d’odeur Séparation des composants Effritement Mauvais étiquetage Conditionnement incomplet Autres : ………………………………………………………………………… ………………………………………………………………………………

Décrivez en détails votre plainte ………………………………………………………………………………………………

…………………………………………………………………………………………………………………………………………………………

C. Condition de stockage

Le produit requiert-il une réfrigération ? Oui Non Autres : détailler

Le produit est-il disponible à la Formation Sanitaire ? Oui Non

Le produit est-il retourné par le patient après qu’il ait été dispensé

Oui Non

La conservation/stockage du produit est-elle conforme aux directives du producteur ou du MINISANTE

Oui Non

REPUBLIQUE DU RWANDA

MINISTERE DE LA SANTE

N° de la fiche: ……../…….


38

D. Circonstances et moment de détection du problème de qualité du produit A quel moment avez-vous constaté que le médicament avait un problème de qualité ? Avant la prise du médicament Au cours de la prise du médicament A la fin de la prise du médicament Quand un proche (parent ou ami/e) a pris ce médicament Quand un patient que vous traitez/suivez a pris ce médicament Autres : spécifiez…………………………………………………………………….

Dans quelle circonstance avez-vous constaté ce problème de qualité

A la suite d’une complication de l’état d’un patient/ami(e)/parent après la prise du médicament

A la suite d’une hospitalisation du patient après la prise du médicament

A la suite d’une plainte du patient A la suite d’un constat personnel dans le lieu de

stockage du médicament

Si vous ou quelqu’un d’autre aviez déjà pris ce médicament, avez-vous constaté des symptômes/signes cliniques suspects ? Oui Non Si oui veuillez remplir la fiche de notification des événements indésirables.

Votre appui au système de Pharmacovigilance est grandement apprécié.

La soumission d’une plainte n’implique en aucun cas que le médicament ou le prestataire des soins ont causé ou contribué à l’apparition de

cet événement. Toute information est strictement confidentielle et le personnel du système de Pharmacovigilance ne mettra jamais en public

l’identité du rapporteur/notificateur en réponse à une quelconque demande publique.

L’information que vous fournissez contribuera à l’amélioration de la qualité des soins et la sécurité d’utilisation du médicament.

Une fois remplie, veuillez envoyer cette fiche au Centre National de Pharmacovigilance ou au sous comité de Pharmacovigilance dans

l’hôpital qui vous est proche.


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B.2. ENGLISH VERSION: POOR QUALITY MEDICINE NOTIFICATION FORM

National Pharmacovigilance and Medicine Information Center

Poor Quality Medicine Notification Form

A. Information on the notificator Please tick your status 1. Patient

2. Healthcare professional 3. Other ( specify)

Date of notification:

……..D/………..M/…………………Y

Address of notificator

Village : Sector

Cell : District

Any other available address (cell phone/email):

Has the person who made the notification come in direct contact with the reported product?

Yes No

B. Product identity Brand Name Generic name

Batch/ lot number Date of manufacture

Date of expiry

Date of receipt Name of manufacturer

Name of distributor/supplier

Distributor/supplier’s address

PRODUCT FORMULATION (tick appropriate box) COMPLAINT (tick appropriate box/boxes)

Oral tablet/capsule Oral suspension/syrup Injection

Diluent Powder for reconstitution of suspension Powder for reconstitution of injection Eye drops Ear drops Nebuliser solution Cream/ointment/liniment/paste Other :……………………………………………………

Colour change Separating Powdering/crumbling Caking Moulding Change of odour Mislabelling Incomplete pack Other: ………………………………………………………………………… ……………………………………………………………………………

Describe complaint in detail …………………………………………………………………………………………………… ………………………………………………………………………………………………………………………………………………………… …………………………………………………………………………………………………………………………………………………………..

C. Storage conditions Does the product require refrigeration? Yes No Other details(if necessary):

Was the product available at facility? Yes No

Was product dispensed and returned by client? Yes No

Was the product stored according to manufacturer/MoH recommendations

Yes No

D. Circumstance and time of poor quality detection At which time did you notice that the poor quality problem? Before taking the product While I took the product After I took the product When relatives took the product When my patient took this product Other…………………………………………………………

In which circumstances did you notice the poor quality problem? When I noticed complication on my patient/relative after he/she took this product

When a patient was hospitalized after taking this product After a complaint of patient who is under this medication After personal observation/experience of the medicine’s poor

quality in the storage room

Have you experienced any adverse event or did you receive any complaint after taking this medicine? Yes No If you, or any other person has already taken this medicine and experienced any health problem, please complete the adverse event notification form.

REPUBLIC OF RWANDA

MINISTRY OF HEALTH




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Your support in this Pharmacovigilance program is appreciated.

Submission of a complaint does not constitute an admission that medical personnel or manufacturer or the product caused or contributed to the event. All information is held in strict confidence and programme staff is not expected to and will not disclose reporter/notificator’s identity in response to any public request. Information supplied by you will contribute to the improvement of medicine safety and therapy in Rwanda. Once completed please send to: National Pharmacovigilance and Medicine Information Center (NPMIC) or to the Drug and

Therapeutic Committee (DTC) of the nearest hospital.


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ANNEX C. MEDICINE INFORMATION REQUEST FORM


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ANNEX D. WHO CAUSALITY ASSESSMENT CRITERIA


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ANNEX E. WHO TOXICITY GRADING SCALE


44


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http://www.icssc.org/Documents/Resources/AEManual2003AppendicesFebruary_06_2003%20fi

nal.pdf


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ANNEX F. MEDICATION ERROR REPORTING AND PREVENTION SCALE


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ANNEX G. PATIENT ALERT CARD

G.1. ENGLISH VERSION: PATIENT ALERT CARD

PATIENT ALERT CARD

Patient name: ……………………………………………………………………………

Date of birth: ……………………………… Gender : M F

Height/Weight: …………………………………………

ID/passport number: ……………………………..

Place of issue of the alert card: PV subcommittee of Hospital……………………………….

Date when the card was issued: ...../……./……

Responsible medicine: ……………………………………………….

Types of intolerance:

……………..……………………………………………………………………………..…………

……………………………………………………………………………………

Please hold always this card with you to be presented to any healthcare provider in any

consultation session.

Itwaze iteka iyi karita kandi wibuke kuyereka muganga mu gihe cyose ugiye kwivuza.

Signature and stamp of the hospital

REPUBLIC OF RWANDA

MINISTRY OF HEALTH


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G.2. KINYARWANDA VERSION: IKARITA MPURUZA Y’UMURWAYI

IKARITA MPURUZA Y’UMURWAYI

Amazina y’umurwayi………………………………………………………………………

Igihe yavukiye cyangwa imyaka: ………………………………

Igitsina : Gabo Gore

Uburebure: …………………………………………

Nimero y’indangamuntu/pasiporo: ……………………………..

Aho iyi karita yandikiwe: Ibitaro bya………………………………….

Itariki iyi karita yandikiweho: ......../……./………

Ubwoko bw’ingaruka mbi yatewe n’umuti: ……………………………………………………….

…………………………………………………………………………………………………….

Izina/ubwoko bw’umuti wateye icyo kibazo:……………………………………………………

Itwaze iteka iyi karita kandi wibuke kuyereka muganga igihe cyose ugiye kwivuza.

Kashe y’ibitaro byatangiwemo iyi karita

REPUBULIKA Y’U RWANDA

MINISITERI Y’UBUZIMA


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ANNEX H. GLOSSARY OF MEDICINE SAFETY TERMS

http://psnet.ahrq.gov/glossary.aspx Adverse medicine reaction (AMR)/adverse drug reaction (ADR)

A response to a medicine which is noxious and unintended, and which occurs at a dose normally

used in humans for prophylaxis, diagnosis, or therapy of disease, or for the modification of

physiological function.

The term adverse drug reaction should be considered for harmful or seriously unpleasant effects

occurring at doses intended for therapeutic, prophylactic or diagnostic effect and which calls for

reduction of dose or withdrawal of the drug and/or forecast hazard from future administration.

Adverse event /adverse experience

Any untoward medical occurrence that may present during treatment with a pharmaceutical

products but which does not necessarily have a causal relationship with the treatment

Medication error

A medication error is any preventable event that may cause or lead to inappropriate medication

use or patient harm while the medication is in the control of the healthcare professional, patient,

or consumer. Such events may be related to professional practice, health care products,

procedures, and systems, including prescribing; order communication; product labeling,

packaging, and nomenclature; compounding; dispensing; distribution; administration; education;

monitoring; and use.

(Source: National Coordinating Council for Medication Error Reporting and Prevention. Available from:

http://www.nccmerp.org/aboutMedErrors.html)

Medicine/Drug

A pharmaceutical product, used in or on human body for the prevention (prophylaxis, mitigation

diagnosis) or treatment of disease, or for the modification of physiological function

Medicine safety surveillance

The processes involved in the collection, collation, analysis and dissemination of data and other

activities carried out in relations to safeguarding the safety and effectiveness of pharmaceuticals

and related products

Medicine safety system

All organisations, institutions, and resources that contribute to efforts, whether in personal health

care, public health services or through intersectorial initiatives, whose primary purpose is to

protect the public from harm related to the use of medicines.

Periodic safety update report A periodic safety update report is an update of the worldwide safety experience of a product

obtained at defined times post registration.

http://psnet.ahrq.gov/glossary.aspx

http://www.nccmerp.org/aboutMedErrors.html


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Pharmacovigilance

Pharmacovigilance is the science and activities relating to the detection, assessment,

understanding and prevention of adverse effects or any other possible drug-related problems.

Recently, its concerns have been widened to include herbals, traditional and complementary

medicines, blood products, biologicals, medical devices and vaccines.

Aims of Pharmacovigilance

The specific aims of Pharmacovigilance are to—

Improve patient care and safety in relation to the use of medicines and all medical and

paramedical interventions

Improve public health and safety in relation to the use of medicines

Detect problems suspected to be caused by medicines and communicate the findings in a

timely manner

Contribute to the assessment of benefit, harm, effectiveness and risk of medicines,

leading to the prevention of harm and maximization of benefits;

Encourage safe, rational and more effective (including cost-effective) use of medicines;

Promote understanding, education and clinical training in Pharmacovigilance and its

effective communication to the public.

Serious adverse event

Serious adverse event is any untoward occurrence that

1. Is life-threatening or fatal

2. Causes or prolongs hospital admission

3. Causes persistent incapacity or disability

4. Concerns misuse or dependence

5. Causes congenital anomaly/birth defect

Signal

A signal refers to ―reported information on a possible causal relationship between an adverse

event and a drug, the relationship being unknown or incompletely documented previously.‖

Usually more than a single report is required to generate a signal, depending upon the

seriousness of the event and the quality of the information.

Side effect

Any unintended effect of a pharmaceutical products occurring at doses normally used in patients,

which is related to the pharmacological properties of the medicine

Spontaneous reporting

A system whereby case reports of adverse drug events are voluntarily submitted by health

professionals and pharmaceutical manufacturers to the national regulatory authority/

Pharmacovigilance centre

Toxicity

Toxicity implies cell damage from a direct action of the drug, often at a high dose, e.g., liver

damage from Paracetamol overdose.

Unexpected adverse reaction

An adverse reaction, the nature or severity of which is not consistent with domestic labeling or

market authorization, or expected from the characteristics of the drug.


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ANNEX I : DEFINITION AND CLASSIFICATION OF ADR

WHO defines adverse reaction as a response to a medicine which is noxious and unintended, and

which occurs at doses normally used in patients. In this prescription, it is of importance that it

concerns the response of a patient in which individual factors may play an important role, and

that the phenomenon is noxious.

A classification of ADRs reveals how they are related and draws attention to the common factors

involved in the cause of reactions within the same group, thus enabling similar steps to be taken

to treat or prevent them. Adverse drug reactions are categorized as Type A, Type B, or Type C in

this method of classification.

Type A (augmented) adverse drug reactions

These reactions are the result of an exaggerated, but otherwise normal pharmacological

action of a drug given in the usual therapeutic doses.

Type A reactions are largely predictable on the basis of a drug’s known pharmacology.

They are usually dose-dependant and although their incidence and morbidity in the

community is often high, their mortality is generally low.

Type B (bizarre) adverse drug reactions

These reactions are totally aberrant effects that are not expected from the known

pharmacological actions of a drug when given in the usual therapeutic doses to a patient

whose body handles the drug in a normal way.

They are usually unpredictable and are not observed during conventional

pharmacological and toxicological screening programs.

Although their incidence and morbidity are low, their mortality may be high.

Type C adverse drug reactions

These reactions refer to situations where the use of a drug, often for unknown reasons,

increases the frequency of a ―spontaneous‖ disease.

They may be both serious and common and may have pronounced effects on public

health.

They may also be coincidental and may cause long-term effects. There is often no

suggestive time relationship and the connection may be very difficult to prove.


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